Aortic Aneurysm, AbdominalPhase 1AAA:STOPNCT00349947
Exercise Therapy to Treat Adults With Abdominal Aortic Aneurysms
A Phase 1 study testing Exercise Program in people with Aortic Aneurysm, Abdominal, run by Stanford University at 3 sites in United States.
Trial summary
An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta, which is a large blood vessel in the abdomen. If an AAA ruptures, it can be life-threatening. Research has shown that sedentary individuals are at increased risk of developing AAAs. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2006to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Small AAA less than 5.5 cm in size
- Over age 50
Who cannot join
- Patients with congenital aneurysm syndromes such as Ehlers-Danlos' or Marfan's
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Palo Alto Veterans Affairs Health Care System
Palo Alto, California
Kaiser Permanente Hospitals of Northern California
Santa Clara, California
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Abdominal Aortic Aneurysms: Simple Treatment or Prevention (AAA: STOP)
An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta, which is a large blood vessel in the abdomen. If an AAA ruptures, it can be life-threatening. Research has shown that sedentary individuals are at increased risk of developing AAAs. This study will evaluate the effectiveness of an exercise program at limiting the growth of small AAAs in older individuals.
Read the detailed description
AAAs are common among older individuals, and are the 10th leading cause of death for men over the age of 55. A ruptured AAA usually leads to death. Therefore, early detection and treatment are critical. Currently, there are several surgical treatment options available, but there is no proven non-surgical treatment for AAAs. Research has shown that physical inactivity may be linked to the development of AAAs. The purpose of this study is to gather information on AAA risk factors, and to evaluate the effectiveness of an exercise program at preventing the growth of small AAAs in older individuals.
This study will be composed of three individual projects. Project 1 will enroll 1400 individuals with small AAAs. Project 2 will enroll 1000 individuals with unknown aortic size and previously tested exercise capacity. Both groups of participants will attend one study visit, at which time their medical history and physical activity history will be recorded, vital signs will be collected, and blood and urine sample will be given. Questionnaires will be completed to document physical activity levels and AAA risk factors. An abdominal ultrasound will be performed to measure the size of the aorta or AAA. Participants in Project 2 will also take part in a treadmill exercise test, during which heart rate and blood pressure will be recorded, and heart activity will be monitored by an electrocardiogram (ECG).
The third project will last 3 years and will enroll 340 individuals from Project 1. Participants will be randomly assigned to either an exercise program or a usual activity group. An initial screening visit will include medical history review, vital sign measurements, blood collection, questionnaires, an abdominal ultrasound, a positron emission tomography (PET) scan, a computed tomography (CT) scan, and a magnetic resonance imaging (MRI) scan.
Participants in the exercise program will complete an exercise test at the beginning of the study and every 6 months for the duration of the study. Participants who live within 15 miles of the Palo Alto VA Hospital will take part in a supervised aerobic exercise program 3 days a week. Participants who live farther than 15 miles from the hospital will receive a detailed exercise plan and will exercise on their own while wearing a heart rate and activity tracking device. They will also attend monthly study visits for review of their progress. All participants assigned to the exercise program will be encouraged to increase their daily exercise. Each day they will wear a pedometer; twice a month they will wear a global positioning system (GPS) and heart rate monitor. Participants assigned to the usual activity group will wear pedometers each day and will maintain their usual level of physical activity. At yearly study visits, blood will be collected and physical activity levels will be assessed.
All Project 3 participants with AAAs smaller than 4 cm will undergo an ultrasound and blood collection once a year; participants with AAAs 4 cm or larger will undergo the same procedures every 6 months. At the end of 3 years, all participants will attend a final study visit at which time their medical history will be reviewed and blood will be collected. They will also undergo an abdominal ultrasound, and PET, CT, and MRI scans.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Exercise Program
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
Participants who live within 15 miles of the Palo Alto VA Hospital will take part in a supervised aerobic exercise program 3 days a week. Participants who live farther than 15 miles from the hospital will receive a detailed exercise plan and will exercise on their own while wearing a heart rate and activity tracking device. They will also attend monthly study visits for review of their progress. All participants assigned to the exercise program will be encouraged to increase their daily exercise. Each day they will wear a pedometer; twice a month they will wear a global positioning system (GPS) and heart rate monitor.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will take part in an exercise program. Receives: Behavioral: Exercise Program |
| 2 | No intervention | Participants will take part in a usual activity group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth rate of AAAs
Measured: Measured at Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startNov 2006
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ronald L. Dalman, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349947
- Sponsor's protocol ID
- 391
- Other IDs
- 5P50HL083800, P50HL083800-01
- Acronym
- AAA:STOP
- Status last verified
- Jun 2013
- First submitted
- 6 Jul 2006
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vainshelboim B, Rao S, Chan K, Lima RM, Ashley EA, Myers J. A comparison of methods for determining the ventilatory threshold: implications for surgical risk stratification. Can J Anaesth. 2017 Jun;64(6):634-642. doi: 10.1007/s12630-017-0862-8. Epub 2017 Apr 5.
PubMed 28382529Bianchi VE, Herbert WG, Myers J, Ribisl PM, Miller LE, Dalman RL. Relationship of obstructive sleep apnea and cardiometabolic risk factors in elderly patients with abdominal aortic aneurysm. Sleep Breath. 2015 May;19(2):593-8. doi: 10.1007/s11325-014-1053-2. Epub 2014 Sep 10.
PubMed 25204854Betz HH, Myers J, Jaffe A, Smith K, Dalman R. Reproducibility of the Veterans Physical Activity Questionnaire in an elderly population. J Phys Act Health. 2015 Mar;12(3):376-81. doi: 10.1123/jpah.2013-0124. Epub 2014 Apr 17.
PubMed 24763187Myers J, McElrath M, Jaffe A, Smith K, Fonda H, Vu A, Hill B, Dalman R. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014 Jan;46(1):2-9. doi: 10.1249/MSS.0b013e3182a088b8.
PubMed 23793234Myers J, Dupain M, Vu A, Jaffe A, Smith K, Fonda H, Dalman R. Agreement between activity-monitoring devices during home rehabilitation: a substudy of the AAA STOP trial. J Aging Phys Act. 2014 Jan;22(1):87-95. doi: 10.1123/japa.2012-0133. Epub 2013 Feb 14.
PubMed 23416349
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Aortic Aneurysms: Simple Treatment or Prevention (AAA: STOP)
- ClinicalTrials.gov ID
- NCT00349947
- Acronym / sponsor ID
- AAA:STOP / 391
- Conditions
- Aortic Aneurysm, Abdominal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta, which is a large blood vessel in the abdomen. If an AAA ruptures, it can be life-threatening. Research has shown that sedentary individuals are at increased risk of developing AAAs. This study will evaluate the effectiveness of an exercise program at limiting the growth of small AAAs in older individuals.
Detailed description
AAAs are common among older individuals, and are the 10th leading cause of death for men over the age of 55. A ruptured AAA usually leads to death. Therefore, early detection and treatment are critical. Currently, there are several surgical treatment options available, but there is no proven non-surgical treatment for AAAs. Research has shown that physical inactivity may be linked to the development of AAAs. The purpose of this study is to gather information on AAA risk factors, and to evaluate the effectiveness of an exercise program at preventing the growth of small AAAs in older individuals.
This study will be composed of three individual projects. Project 1 will enroll 1400 individuals with small AAAs. Project 2 will enroll 1000 individuals with unknown aortic size and previously tested exercise capacity. Both groups of participants will attend one study visit, at which time their medical history and physical activity history will be recorded, vital signs will be collected, and blood and urine sample will be given. Questionnaires will be completed to document physical activity levels and AAA risk factors. An abdominal ultrasound will be performed to measure the size of the aorta or AAA. Participants in Project 2 will also take part in a treadmill exercise test, during which heart rate and blood pressure will be recorded, and heart activity will be monitored by an electrocardiogram (ECG).
The third project will last 3 years and will enroll 340 individuals from Project 1. Participants will be randomly assigned to either an exercise program or a usual activity group. An initial screening visit will include medical history review, vital sign measurements, blood collection, questionnaires, an abdominal ultrasound, a positron emission tomography (PET) scan, a computed tomography (CT) scan, and a magnetic resonance imaging (MRI) scan.
Participants in the exercise program will complete an exercise test at the beginning of the study and every 6 months for the duration of the study. Participants who live within 15 miles of the Palo Alto VA Hospital will take part in a supervised aerobic exercise program 3 days a week. Participants who live farther than 15 miles from the hospital will receive a detailed exercise plan and will exercise on their own while wearing a heart rate and activity tracking device. They will also attend monthly study visits for review of their progress. All participants assigned to the exercise program will be encouraged to increase their daily exercise. Each day they will wear a pedometer; twice a month they will wear a global positioning system (GPS) and heart rate monitor. Participants assigned to the usual activity group will wear pedometers each day and will maintain their usual level of physical activity. At yearly study visits, blood will be collected and physical activity levels will be assessed.
All Project 3 participants with AAAs smaller than 4 cm will undergo an ultrasound and blood collection once a year; participants with AAAs 4 cm or larger will undergo the same procedures every 6 months. At the end of 3 years, all participants will attend a final study visit at which time their medical history will be reviewed and blood will be collected. They will also undergo an abdominal ultrasound, and PET, CT, and MRI scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Exercise ProgramParticipants will take part in an exercise program. |
| 2 | No intervention | –Participants will take part in a usual activity group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Small AAA less than 5.5 cm in size
- Over age 50
Key exclusion criteria (1 listed)
- Patients with congenital aneurysm syndromes such as Ehlers-Danlos' or Marfan's
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramParticipants who live within 15 miles of the Palo Alto VA Hospital will take part in a supervised aerobic exercise program 3 days a week. Participants who live farther than 15 miles from the hospital will receive a detailed exercise plan and will exercise on their own while wearing a heart rate and activity tracking device. They will also attend monthly study visits for review of their progress. All participants assigned to the exercise program will be encouraged to increase their daily exercise. Each day they will wear a pedometer; twice a month they will wear a global positioning system (GPS) and heart rate monitor. | Behavioural | 1 |
Primary outcome
Growth rate of AAAs
Time frame: Measured at Year 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
- Derived from this study: PubMed 28382529Vainshelboim B, Rao S, Chan K, Lima RM, Ashley EA, Myers J. A comparison of methods for determining the ventilatory threshold: implications for surgical risk stratification. Can J Anaesth. 2017 Jun;64(6):634-642. doi: 10.1007/s12630-017-0862-8. Epub 2017 Apr 5.
- Derived from this study: PubMed 25204854Bianchi VE, Herbert WG, Myers J, Ribisl PM, Miller LE, Dalman RL. Relationship of obstructive sleep apnea and cardiometabolic risk factors in elderly patients with abdominal aortic aneurysm. Sleep Breath. 2015 May;19(2):593-8. doi: 10.1007/s11325-014-1053-2. Epub 2014 Sep 10.
- Derived from this study: PubMed 24763187Betz HH, Myers J, Jaffe A, Smith K, Dalman R. Reproducibility of the Veterans Physical Activity Questionnaire in an elderly population. J Phys Act Health. 2015 Mar;12(3):376-81. doi: 10.1123/jpah.2013-0124. Epub 2014 Apr 17.
- Derived from this study: PubMed 23793234Myers J, McElrath M, Jaffe A, Smith K, Fonda H, Vu A, Hill B, Dalman R. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014 Jan;46(1):2-9. doi: 10.1249/MSS.0b013e3182a088b8.
- Derived from this study: PubMed 23416349Myers J, Dupain M, Vu A, Jaffe A, Smith K, Fonda H, Dalman R. Agreement between activity-monitoring devices during home rehabilitation: a substudy of the AAA STOP trial. J Aging Phys Act. 2014 Jan;22(1):87-95. doi: 10.1123/japa.2012-0133. Epub 2013 Feb 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald L. Dalman, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise Program in people with Aortic Aneurysm, Abdominal, run by Stanford University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth rate of AAAs (time frame: Measured at Year 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00349947, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.